Burns
Conditions
Brief summary
This is a randomized controlled trial to compare viscoelastometric (VE) guided transfusion to standard practice transfusion in severe thermal injury burn excision on the utilization of blood products, effects on coagulation and inflammatory mediators, and how these strategies affect post resuscitation infections.
Detailed description
This is an open labeled study as the viscoelastometric (VE) guided transfusion will be based on the visible VE results. Subjects will be randomized to receive either the standard practice transfusion or VE guided transfusion. Blood samples, standard demographic information, and routine laboratory data will be collected on all subjects in the Burn ICU (BICU) enrolled in the study. VE analysis will be performed on ALL subjects immediately prior to the burn excision, and approximately every 40 minutes while the patient is in the operating room (OR) as well as on arrival to the BICU and every 8 hours depending on their need for ongoing transfusion for a maximum of 24 hours. As our intervention, only the VE based transfusion group will have access to the VE analysis at time of transfusion. The VE results will be used at the discretion of the treating physician based on the VE guided transfusion algorithm. Outcomes include the number and timing of blood products transfused from the time of randomization to 24 hours post randomization and the presence of any 30 day post-transfusion infections.
Interventions
PROCEDUREViscoelastic (VE) Guided Transfusion
A viscoelastic analyzer (ROTEM) will be used to guide the transfusion algorithm during the burn wound excision of subjects enrolled into this arm
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Burn patients admitted to Parkland Hospital with total burn surface area (TBSA) greater than 20%
Exclusion criteria
* Patients admitted to Parkland Hospital for reasons other than burns or for burns less than or equal to 20%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of blood products transfused | 24 hours post randomization | Compare the number of blood products transfused in VE guided transfusion versus standard practice transfusion in burned patients (TBSA \>20%) undergoing burn wound excision will be analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coagulation factors | excision to 24 hours post excision | Compare the effects of VE guided transfusion to standard practice transfusion on the coagulation factor in patients undergoing burn wound excision. Changes in individual coagulation factors will be measured. Will measure other related mediators including coagulation Factors V, VIII, and plasminogen activator inhibitor 1 (PAI-1) which have also been implicated in ATC. |
| Inflammatory Mediators - plasminogen activator inhibitor 1 | excision to 24 hours post excision | Compare the effects of VE guided transfusion to standard practice transfusion on the inflammatory mediators in patients undergoing burn wound excision. Changes in inflammatory mediators will be measured. Further, analysis into interactions between these factors will be studied. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Post transfusion infections | 30 days | Compare the post transfusion infections to the number of blood products transfused for VE guided transfusion and standard practice transfusion in patients undergoing burn wound excision. |
Countries
United States
Outcome results
None listed